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The first company to gain approval from the Food and Drug Administration to sell its over-the-counter COVID tests is recalling nearly 200,000 kits sold by retailers, including Amazon, CVS, target and Walmart after a higher than expected false positive rate.
The recall involves 43 lots distributed to retailers and the Defense Department between April and August, test kit maker Ellume said in a statement. opinion published on its website. The specific batches reported higher positivity rates than seen in clinical trials, prompting the Brisbane, Australia-based company to look into the issue, which it said it is working to resolve.
Illuminated
“After further investigation, we have isolated the cause and confirmed that this incidence of false positives is limited to specific batches,” Dr. Sean Parson, CEO and founder of Ellume said in a statement. declaration. “We recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them manage their health and regain some control of their lives during this pandemic,” added Parson, who apologized for “any stress or difficulties” to those who tested falsely positive.
There were approximately 427,000 tests in the recalled lots, of which approximately 195,000 were unused and subject to recall, the company told CBS MoneyWatch in an emailed statement. About 160,000 of the tests produced negative results considered reliable, while about 42,000 produced positive results, “which include both true positives and false positives,” according to the company.
Ellume notifies those affected by the recall, and those who attempt to use the affected tests will be notified in the company’s app that the test has been recalled and disabled.
People who have purchased an Ellume kit can check if it is part of the recall here, as well as request a replacement test. The company can also be reached Monday through Friday, 9 a.m. to 5 p.m. EST, at 1 (888) 807-1501.
The FDA reported the problem on Tuesday, saying he was working with Ellume to make sure the manufacturing issue was resolved.
Rapid Ellume Antigen Test in december became the first home test to receive emergency use clearance from the FDA. The agency on Monday authorized a new home antigen test, Flowflex from ACON Laboratories.
The Biden administration said last month that it was partnership with retailers including Amazon, Kroger, and Walmart to make rapid home tests cheaper and easier to obtain. The White House has announced in recent days that it will invest still $ 1 billion by putting more tests on the market.
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